Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH. (BERMESyH)

April 22, 2021 updated by: Shaúl Ariel Navarro Lara, Hospital Civil de Guadalajara

Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.

With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance.

Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 60 years
  • Documented HIV-1 infection
  • Stable antiretroviral therapy at least 6 months before enrollment
  • Viral suppression
  • Metabolic syndrome , defined by Adult Treatment Panel-III criteria
  • No previously known kidney or liver disease
  • Signed informed consent

Exclusion Criteria:

  • People younger than 18 years and older than 60 years
  • Prior atherosclerotic cardiovascular disease
  • Diabetes mellitus type 1 or 2
  • Previous use of glucose and/or lipid modifying medications
  • Pregnancy
  • Withdrawal of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo three times daily for 6 months
Drug: Placebo
Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months
Experimental: Berberine
Berberine 500 mg three times daily for 6 months
Drug: Berberine
Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: 24 weeks within randomization
Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months
24 weeks within randomization
Change from baseline lipid profile at 6 months
Time Frame: At the beginning and 24 weeks within randomization
Measurement of total cholesterol, HDL, LDL, triglycerides.
At the beginning and 24 weeks within randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline weight
Time Frame: At the beginning and 24 weeks within randomization
Weight gain or loss measure by kilograms
At the beginning and 24 weeks within randomization
Inflammatory profile
Time Frame: At the beginning and 24 weeks within randomization
Level of pro-inflammatory cytokines
At the beginning and 24 weeks within randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

April 17, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MeSHIV-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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